An effective vaccine may be the only way to stop the HIV pandemic. The purpose of this study is to determine the safety of and immune response to the DNA vaccine, PENNVAX-B with or without an IL-12 adjuvant when given using electroporation.

Frequency of CD8+ T cell responses measured by ICS for IFN-γ and/or IL-2 to HIV PTE peptide pools representing Gag, Pol, and Env [ Time Frame: After the second and third vaccinations ] [ Designated as safety issue: No ]

Frequency of humoral responses detected by HIV-1-specific neutralizing and binding antibody assays from serum samples [ Time Frame: Two weeks after last vaccination ] [ Designated as safety issue: No ]

Participants will receive 3 mg of PENNVAX-B vaccine or placebo at Months 0, 1, and 3.

Biological: PENNVAX-B

DNA vaccine encoding the Gag, Pol, and Env proteins of HIV

Experimental: Group 2

Participants will receive 3 mg of PENNVAX-B vaccine and 1 mg of IL-12 vaccine or placebo at Months 0, 1, and 3.

Biological: PENNVAX-B

DNA vaccine encoding the Gag, Pol, and Env proteins of HIV

Biological: IL-12 DNA plasmids

Adjuvant for HIV vaccines

Experimental: Group 3

Participants will receive 3 mg of PENNVAX-B vaccine and 1 mg of IL-12 vaccine or placebo at Months 0, 1, and 3.

Biological: PENNVAX-B

DNA vaccine encoding the Gag, Pol, and Env proteins of HIV

Biological: IL-12 DNA plasmids

Adjuvant for HIV vaccines

Detailed Description:

An effective and safe vaccine must be developed in order to halt the HIV pandemic. The purpose of this study is to assess the safety and immune response to the HIV DNA vaccine, PENNVAX-B when given with and without an IL-12 adjuvant and delivered via electroporation.

Participants in this study will be randomly assigned to one of three groups and will visit the study clinic 9 times over 9 months. Group 1 will enroll first. Participants in this group will receive 3 mg of the PENNVAX-B or placebo vaccine at Months 0, 1, and 3. Once safety data has been examined for Group 1, Group 2 will begin enrollment. Group 2 participants will receive 3 mg of PENNVAX-B vaccine plus 1 mg of IL-12 adjuvant or placebo at Months 0, 1, and 3. Once Group 1 and Group 2 safety data have been collected Group 3 will begin enrollment. These participants will also receive 3 mg of PENNVAX-B vaccine plus 1 mg of IL-12 adjuvant or placebo at Months 0, 1, and 3.

At clinic visits participants will have physical exams and blood and urine collected. After receiving study injections, participants will be observed in the clinic for at least 30 minutes. In addition, participants will be asked to monitor symptoms for 3 days after each injection.

Eligibility

Ages Eligible for Study:

18 Years to 50 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Access to a participating HVTN CRS and willingness to be followed for the planned duration of the study

Ability and willingness to provide informed consent

Assessment of understanding: volunteer demonstrates understanding of this study and the Step Study results; completes a questionnaire prior to first vaccination, with verbal demonstration of understanding of all questionnaire items answered incorrectly

Volunteers who were born female: negative serum or urine beta human chorionic gonadotropin (β-HCG) pregnancy test performed prior to vaccination on the day of initial vaccination

Reproductive status: A volunteer who was born female must agree to consistently use effective contraception from at least 21 days prior to enrollment through the last required protocol clinic visit for sexual activity that could lead to pregnancy, or not be of reproductive potential, or be sexually abstinent

Volunteers who were born female must also agree not to seek pregnancy through alternative methods, such as artificial insemination or in vitro fertilization until after the last required protocol clinic visit

Exclusion criteria:

Within the 12 months prior to enrollment: excessive daily alcohol use or frequent binge drinking or chronic marijuana abuse or any other illicit drug use

HIV vaccine(s) received in a prior HIV vaccine trial. For potential participants who have received control/placebo in an HIV vaccine trial, documentation of the identity of the study control/placebo must be provided to the HVTN 080 PSRT, who will determine eligibility on a case-by-case basis.

Non-HIV experimental vaccine(s) received within the last 5 years in a prior vaccine trial. Exceptions may be made for vaccines that have subsequently undergone licensure by the FDA or for those who have received control/placebo in an experimental vaccine trial.

Immunosuppressive medications received within 168 days before first vaccination. (Not excluded: [1] corticosteroid nasal spray for allergic rhinitis; [2] topical corticosteroids for mild, uncomplicated dermatitis or [3] oral/parenteral corticosteroids given for non-chronic conditions not expected to recur [length of therapy 10 days or less with completion at least 30 days prior to enrollment])

Blood products received within 120 days before first vaccination

Immunoglobulin received within 60 days before first vaccination

Live attenuated vaccines other than influenza vaccine received within 30 days before first vaccination or scheduled within 14 days after injection

Investigational research agents received within 30 days before first vaccination

Intent to participate in another study of an investigational research agent during the planned duration of the HVTN 080 study

Influenza vaccine or any vaccines that are not live attenuated vaccines and were received within 14 days prior to first vaccination (e.g., tetanus, pneumococcal, Hepatitis A or B, HPV)

Allergy treatment with antigen injections within 30 days before first vaccination or that are scheduled within 14 days after first vaccination

Any medical, psychiatric, occupational, or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety or reactogenicity, or a participant's ability to give informed consent

Malignancy (Not excluded: a participant with a surgical excision and subsequent observation period that in the investigator's estimation has a reasonable assurance of sustained cure or is unlikely to recur during the period of the study.)

Seizure disorder

Asplenia: any condition resulting in the absence of a functional spleen

Psychiatric condition that precludes compliance with the protocol

Pregnant or breastfeeding

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00991354